Regulatory Approval Archives

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Funding
- GT Medical raises $37m to advance bioresorbable radiation tile
  
  Funding January 17, 2025
  
  Robeauté raises $28 million for neurosurgical microrobots
  
  Funding January 15, 2025
  
  Alleviant Medical secures $90m to launch pivotal aortic stent trial
  
  Funding January 15, 2025
  
  Relief Cardiovascular raises $12m for smart transcatheter implant
  
  Funding January 14, 2025
Clinical Trials
- Patient enrollment underway for STIMIT’s diaphragm neurostimulation device
  
  Clinical Trials January 20, 2025
  
  Mainstay Medical study demonstrates benefit of neurostimulation for back pain
  
  Clinical Trials January 17, 2025
  
  CardioFocus has positive pulsed field ablation data for its Centauri system
  
  Clinical Trials January 16, 2025
  
  NanoVibronix “achieves goals” of US trial pilot phase with UroShield
  
  Clinical Trials January 7, 2025
Innovation
- Detection Technology launches all-in-one CT detector system
  
  Innovation January 21, 2025
  
  SS Innovations reports first robotic cardiac telesurgeries
  
  Innovation January 14, 2025
  
  Verathon launches sustainable single-use laryngoscope
  
  Innovation November 29, 2024
  
  VUZE Medical demonstrates new multi-tool 3D guidance in spine surgery
  
  Innovation November 28, 2024
Regulatory Approvals
- FDA grants second clearance to Gravitas Medical’s Entarik System
  
  Regulatory Approvals January 21, 2025
  
  FDA approves MediBeacon’s TGFR system for kidney function assessment
  
  Regulatory Approvals January 21, 2025
  
  FDA grants IDE approval for NextBioMedical’s Nexsphere-F trial
  
  Regulatory Approvals January 20, 2025
  
  SurGenTec receives FDA clearance for synthetic bone graft material
  
  Regulatory Approvals January 20, 2025
Mergers & Acquisitions
- Kaneka acquires EndoStream Medical
  
  Mergers & Acquisitions January 13, 2025
  
  Boston Scientific to acquire remaining ownership stake in Bolt Medical for $664m
  
  Mergers & Acquisitions January 10, 2025
  
  Stryker strikes $4.9 billion deal for Inari Medical
  
  Mergers & Acquisitions January 7, 2025
  
  DHG boost market-leading pressure ulcer prevention portfolio with Sumed acquisition
  
  Mergers & Acquisitions October 18, 2024
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GT Medical raises $37m to advance bioresorbable radiation tile

Robeauté raises $28 million for neurosurgical microrobots

Alleviant Medical secures $90m to launch pivotal aortic stent trial

Relief Cardiovascular raises $12m for smart transcatheter implant

Patient enrollment underway for STIMIT’s diaphragm neurostimulation device

Mainstay Medical study demonstrates benefit of neurostimulation for back pain

CardioFocus has positive pulsed field ablation data for its Centauri system

NanoVibronix “achieves goals” of US trial pilot phase with UroShield

Detection Technology launches all-in-one CT detector system

SS Innovations reports first robotic cardiac telesurgeries

Verathon launches sustainable single-use laryngoscope

VUZE Medical demonstrates new multi-tool 3D guidance in spine surgery

FDA grants second clearance to Gravitas Medical’s Entarik System

FDA approves MediBeacon’s TGFR system for kidney function assessment

FDA grants IDE approval for NextBioMedical’s Nexsphere-F trial

SurGenTec receives FDA clearance for synthetic bone graft material

Kaneka acquires EndoStream Medical

Boston Scientific to acquire remaining ownership stake in Bolt Medical for $664m

Stryker strikes $4.9 billion deal for Inari Medical

DHG boost market-leading pressure ulcer prevention portfolio with Sumed acquisition

Tag: Regulatory Approval

Cercare Medical secures FDA clearance for CT Perfusion Imaging software

FemPulse wins FDA IDE for for overactive bladder neuromod

SyntheticMR wins FDA nod for SyMRI 15 imaging solution

Vision RT wins CE Mark certifications for DoseRT, MapRT and Respiratory...

Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system

Field Medical wins FDA breakthrough designation for pulsed field ablation system

MatOrtho’s ReCerf® Hip Resurfacing Arthroplasty wins regulatory approval

Beyond Air’s LungFit PH system gains European CE mark approval

Neo Medical’s spine care platform fully approved under EU Medical Device...

PixCell Medical gains EU IVDR certification for complete blood count analyser

FDA grants second clearance to Gravitas Medical’s Entarik System

FDA approves MediBeacon’s TGFR system for kidney function assessment

Detection Technology launches all-in-one CT detector system

Patient enrollment underway for STIMIT’s diaphragm neurostimulation device

Guided Solutions Appoints Marco Müller as New Managing Director Germany to Drive Strategic Growth

Guided Solutions Appoints Manu Chhokra as Managing Director for Switzerland

FDA clears portable blood, IV fluid warmer from Mequ

Editors’ Choice: Q1 2024 in MedTech